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Table 13. Antiretroviral Therapy-Associated Common and/or Severe Adverse Effects
(See Appendix B for additional information listed by drug.) (Page 3 of 4)
Adverse Effects NRTIs NNRTIs PIs INSTI EI
Hypersensitivity reaction ABC: NVP: RAL MVC: reported as
(HSR) (excluding rash • HLA-B*5701 screening should be performed prior to • Hypersensitivity syndrome of hepatic part of a syndrome
alone or Stevens initiation of ABC and ABC should not be started if HLA- toxicity and rash that may be related to
Johnson syndrome[SJS]) B*5701 is positive. accompanied by fever, general malaise, hepatotoxicity
fatigue, myalgias, arthralgias, blisters,
• Symptoms of HSR include (in descending frequency): oral lesions, conjunctivitis, facial edema,
fever, skin rash, malaise, nausea, headache, myalgia,
eosinophilia, granulocytopenia,
chills, diarrhea, vomiting, abdominal pain, dyspnea,
lymphadenopathy, or renal dysfunction.
arthralgia, and respiratory symptoms.
• In ARV-naive patients, risk is greater for
• Symptoms worsen with continuation of ABC
women with pre-NVP CD4 count
3
• Median onset of reactions is 9 days; ~ 90% of reactions >250 cells/mm and men with pre-NVP
3
within first 6 weeks CD4 count >400 cells/mm . Overall, risk
is higher for women than men.
• Onset of rechallenge reactions is within hours of
rechallenge dose • 2-week dose escalation of NVP reduces
risk.
• Patients, regardless of HLA-B*5701 status, should not be
rechallenged with ABC if HSR suspected.
Lactic acidosis NRTIs, especially d4T, ZDV, and ddI
• Insidious onset with GI prodrome, weight loss, and
fatigue. May be rapidly progressive, with tachycardia,
tachypnea, jaundice, muscular weakness, mental status
changes, respiratory distress, pancreatitis, and organ
failure.
• Mortality up to 50% in some case series, especially in
patients with serum lactate >10 mmol/L
• Females and obese patients at increased risk.
Laboratory findings:
• ↑ lactate (often >5 mmol/L), anion gap, AST, ALT, PT,
bilirubin
• ↑ amylase and lipase in patients with pancreatitis
• arterial pH, serum bicarbonate, serum albumin
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents K-10
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